Clinical trial failure risk - inherent 90%+ attrition rate for oncology drugs from Phase 1 to approval; single negative readout can eliminate program value
Regulatory pathway uncertainty - FDA requirements for novel mechanisms (T-cell engagers, cell therapies) evolving; potential for additional trials, endpoints, or safety monitoring beyond initial expectations
Reimbursement environment - payer pressure on oncology drug pricing intensifying; potential for restricted access even with approval if cost-effectiveness questioned
Technology platform risk - if core scientific hypotheses (target selection, mechanism design) prove flawed, entire pipeline value compromised
Crowded T-cell engager space - multiple large pharma and biotech competitors developing bispecific antibodies and CAR-T therapies targeting similar indications; risk of being out-competed on efficacy, safety, or time-to-market
Big Pharma in-house development - companies like Amgen, Regeneron, AbbVie have substantial internal oncology pipelines and may not need external partnerships
Acquisition risk by competitors - if rival programs demonstrate superior data, potential acquirers may pursue alternatives, limiting CGEM's strategic optionality
Cash runway risk - with $100M annual burn and pre-revenue status, company will require additional financing within 12-24 months; equity raises are dilutive to existing shareholders
Financing market risk - ability to raise capital depends on biotech sector sentiment; adverse market conditions (2022-style biotech bear market) could force unfavorable terms or strategic alternatives
No debt cushion - while zero leverage is positive for solvency, company lacks non-dilutive financing options if equity markets close
StructuralCompetitiveBalance Sheet
